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Improving the Self-Efficacy of African American Parents in Infant Supine Sleep

Improving the Self-Efficacy of African American Parents in Infant Supine Sleep

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01707173
Acronym
PrAAIS
Enrollment
735
Registered
2012-10-16
Start date
2012-10-31
Completion date
2016-04-30
Last updated
2016-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

African American Infant Sleep Beliefs and Practices

Keywords

SIDS

Brief summary

This is a research study of African American parents/caregivers of newborns. The purpose of this research study is to learn what type of educational materials about infant safety and safe infant sleep are most effective and acceptable to parents and caregivers. The investigators will compare the responses of parents who receive enhanced materials to the responses of parents who receive the ordinary materials that are currently in use.

Detailed description

The goal of the proposed research is to determine whether a tailored multi-media mailed intervention is superior to standard non-tailored print brochures along with a generic DVD in increasing the prevalence of African American infant supine sleep during the first six months of life.

Interventions

Using information gleaned from interviews, educational print materials tailored to the participant's beliefs about infant safe sleep practices, will be mailed to the participants home at 2 separate times over a 6 month period along with a culturally relevant DVD with safe sleep information

BEHAVIORALStandard Education

Participants will receive currently available publications about infant sleep from the American Academy of Pediatrics and the AAP at 2 separate times over a 6 month period along with a generic DVD about infant safety practices

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

- \- Self-identified AA adult parents and primary caregivers (≥ 18 years of age) of newborns ≤ four weeks old at the time of the infant's first office visit to the pediatrician.

Exclusion criteria

* Foster parents and temporary guardians: * Prior study participants: * Parents without a reliable phone number: * Parents without ready access to a DVD player: an ownership of a DVD player,

Design outcomes

Primary

MeasureTime frame
Infant's usual sleep position per parental reportChange in position from study entry to infant ages 3 months and to six months; change in position from infant ages 3 months to 6 months
Infants position for last night's sleep per parental reportChange in position from study entry to infant ages 3 months and six months; change in position from infant age 3 months to 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026